MAUDE Adverse Event Report: CRYOLIFE, INC. HERO GRAFT; VASCULAR GRAFT

Model Number HERO 1002

Device Problem Kinked (1339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2015

Event Type  malfunction  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to the report from the representative, "hero graft placement on (b)(6) yr old female.Interventional radiology (ir) implanted venous outflow component (voc successfully).The surgeon took over to implant av graft and complete the hero graft procedure.He attached the clamped voc to the av graft prior to tunneling the voc to the delto-pectoral grove (dpg).He then made an incision at the dpg and used a hemostat the tunnel the connected components, repositioning twice to avoid linking and twisting.Following the successful tunnel, the surgeon removed the clamp; no blood back flowed in the graft.I suggested possible kinking of the av graft at the connection per my observation during tunneling.I explained that the av graft was designed to be replaced, and therefore could be disconnected from the voc in assess possible kinking and troubleshoot why there was no blood backflow.The surgeon attempted to disconnect the av graft from the voc.When pulling apart, the graft underneath the clear connector cover disconnected away from the connector.The surgeon tried to push the graft back under the clear cover.I suggested replacing the av graft with a new component.The surgeon continued to tunnel the full hero graft.He then expressed concern about the connector and i again suggested replacing the av graft.He agreed and i obtained a new av graft component from or supply.The surgeon explanted lot# h14av015 ref# hero 1002.He then implanted lot# h14av015 ref# hero 1002 expiration 2016-03-20.After implantation, the surgeon flushed the hero graft with hep saline and assessed for blood back flow, which was obtained.He then continued with the remainder of the case." additional information from the rep indicated that the cause of the kinking was not confirmed.

• Brand Name: HERO GRAFT
• Type of Device: VASCULAR GRAFT
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• Manufacturer (Section G): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• Manufacturer Contact: sandra o'reilly ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 4916326
• MDR Text Key: 22409568
• Report Number: 1063481-2015-00111
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Report Date: 07/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: HERO 1002
• Device Lot Number: H14AV015
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 43 YR